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Overview

This tutorial demonstrates how to review and update evaluations in an existing qualification plan without adding or changing project snapshots. This is useful when:

  • You want to modify plot configurations
  • You need to reorganize report sections
  • You’re updating plot assignments or building block references
  • You want to add or modify comparison plots (CT, GOF, DDI, PK ratio plots)
  • You need to adjust building block or parameter inheritance

This is the most common workflow when maintaining an established qualification plan where the underlying models haven’t changed, but the qualification report structure or evaluations need updates.

We’ll use the qualification plan for UGT1A1- and UGT1A9-mediated drug-drug interactions (DDI) from the Qualification-DDI-UGT repository as our example.

Prerequisites

  • The ospsuite.qualificationplaneditor package installed
  • An existing qualification plan JSON file
  • Understanding of what evaluations you want to modify

Workflow Overview

Updating a qualification plan involves:

  1. Load the qualification plan: Convert the existing plan to Excel
  2. Edit evaluations: Modify plot configurations, sections, and assignments
  3. Convert back to JSON: Generate the updated qualification plan
  4. Test and validate: Run the updated plan to verify changes

Step 1: Define File Paths

Start by specifying your qualification plan and output files:

# Existing qualification plan (included with package for this example)
qualificationPlan <- "qualification_ugt.json"

# Output Excel file name
excelFile <- "qualification_ugt.xlsx"

Note: For your own projects, replace "qualification_ugt.json" with the path to your qualification plan. This can be: - A local file path: "C:/Projects/MyQualification/plan.json" - A GitHub URL: "https://raw.githubusercontent.com/Org/Repo/main/qualification_plan.json"

Step 2: Convert Qualification Plan to Excel

Convert your qualification plan to Excel format. Notice that we only provide the qualificationPlan parameter - we do not provide snapshotPaths since we’re not adding or changing projects:

toExcelEditor(
  fileName = excelFile, 
  qualificationPlan = qualificationPlan
)
#> 
#> ── Exporting to Excel Editor ───────────────────────────────────────────────────
#>  Copying Excel Template to qualification_ugt.xlsx
#>  Copying Excel Template to qualification_ugt.xlsx [191ms]
#> 
#>  Checking for Qualification Plan
#>  Qualification Plan: qualification_ugt.json
#>  Checking for Qualification Plan Checking for Qualification Plan [32ms]
#> 
#>  Exporting Projects Data
#>  Exporting Projects Data [63ms]
#> 
#>  Exporting Simulation Outputs Data
#>  Exporting Simulation Outputs Data [573ms]
#> 
#>  Exporting Simulation Observed Data
#>  Exporting Simulation Observed Data [262ms]
#> 
#>  Exporting Observed Data
#>  Exporting Observed Data [30ms]
#> 
#>  Exporting Building Block Data
#> 
#>  Exporting Building Block Data── Qualification Plan ──
#>  Exporting Building Block Data
#>  Exporting Building Block Data Exporting Building Block Data [289ms]
#> 
#>  Exporting Schema Data
#>  Exporting Schema Data [20ms]
#> 
#>  Exporting Sections
#>  Exporting Sections [24ms]
#> 
#>  Exporting Intro and Inputs
#>  Exporting Intro and Inputs [27ms]
#> 
#>  Exporting Simulation Parameters Settings
#>  Exporting Simulation Parameters Settings [26ms]
#> 
#>  Exporting All Plots Settings
#>  Exporting All Plots Settings [27ms]
#> 
#>  Exporting Comparison Time Profile Plot Settings
#>  Exporting Comparison Time Profile Plot Settings [71ms]
#> 
#>  Exporting GOF Merged Plot Settings
#>  Exporting GOF Merged Plot Settings [50ms]
#> 
#>  Exporting DDI Ratio Plot Settings
#>  Exporting DDI Ratio Plot Settings [69ms]
#> 
#>  Exporting Global Plot Settings
#>  Exporting Global Plot Settings [22ms]
#> 
#>  Exporting Global Axes Settings
#>  Exporting Global Axes Settings [43ms]
#> 
#>  Saving extracted data into qualification_ugt.xlsx
#>  Saving extracted data into qualification_ugt.xlsx [434ms]

What This Does

When you convert without snapshots, the function:

  1. Reads the qualification plan: Parses the JSON file
  2. Extracts all content:
    • Projects and their metadata
    • All evaluations (plots, sections, inputs)
    • Building block and parameter inheritance
    • Plot configurations and mappings
    • Report structure (sections, introduction)
    • Global settings
  3. Populates Excel worksheets: Creates editable sheets for:
    • MetaInfo: Schema version
    • Projects: All project definitions (read-only, shown in grey)
    • Simulations_Outputs: Available outputs (read-only)
    • Simulations_ObsData: Observed data links (read-only)
    • ObsData: Observed dataset definitions (Type is editable)
    • BB: Building block inheritance (fully editable)
    • SimParam: Parameter inheritance (fully editable)
    • All_Plots: Individual plot evaluations (fully editable)
    • CT_Plots/CT_Mapping: Comparison time profile plots (fully editable)
    • GOF_Plots/GOF_Mapping: Goodness of fit plots (fully editable)
    • DDIRatio_Plots/DDIRatio_Mapping: DDI ratio plots (fully editable)
    • PKRatio_Plots/PKRatio_Mapping: PK ratio plots (fully editable)
    • Sections: Report section structure (fully editable)
    • Intro: Introduction file reference (fully editable)
    • Inputs: Building block documentation (fully editable)
    • GlobalPlotSettings: Plot appearance settings (fully editable)
    • GlobalAxesSettings: Axis configuration (fully editable)
    • Lookup: Reference tables (read-only)
  4. Applies formatting:
    • All projects will be grey (unchanged) since no new snapshots were provided
    • Data validation dropdowns are enabled
    • Read-only sheets should not be edited; modifying them can cause validation or conversion errors when the Excel file is imported back into the tool

Expected Result

The Excel file is now ready for editing. All existing content is preserved and can be modified as needed.

Step 3: Edit the Excel File

Open the Excel file to review and modify evaluations:

utils::browseURL(excelFile)

Common Evaluation Updates

Here are the most common types of updates when maintaining a qualification plan:

A. Reorganize Report Sections (Sections sheet)

Add new sections:

Section Reference | Section Title           | Parent Section
------------------|-------------------------|---------------
3.1-new          | New Results Section     | 3-results
3.1.1-subsection | Detailed Analysis       | 3.1-new

Rename or restructure: - Modify section titles for clarity - Change parent-child relationships - Reorder by changing section references

B. Reassign Plots to Different Sections (All_Plots sheet)

Before:

Project  | Simulation | Output       | Section Reference
---------|------------|--------------|------------------
Project1 | Sim1       | Concentration| 2-methods

After (moved to results):

Project  | Simulation | Output       | Section Reference
---------|------------|--------------|------------------
Project1 | Sim1       | Concentration| 3-results

Or remove from report (leave section empty):

Project  | Simulation | Output       | Section Reference
---------|------------|--------------|------------------
Project1 | Sim1       | Concentration| [empty - excluded]

C. Modify Comparison Time Profile Plots (CT_Plots and CT_Mapping)

Update plot properties (CT_Plots): - Change axes labels, titles, or descriptions - Modify scaling (linear vs. logarithmic) - Update section assignments - Change plot dimensions

Update plot mappings (CT_Mapping): - Add or remove simulation outputs from plots - Change which observed data is compared - Modify plot groupings

Example - Adding a simulation to an existing plot: In CT_Mapping, add a row:

PlotId | Project  | Simulation | Output       | ObservedData
-------|----------|------------|--------------|-------------
CT-01  | Project2 | NewSim     | Concentration| ObsData-X

D. Create or Modify GOF Plots (GOF_Plots and GOF_Mapping)

Goodness of fit plots typically require:

In GOF_Plots: Define the plot with settings

PlotId   | Title                    | Section Reference
---------|--------------------------|------------------
GOF-01   | Model Validation Summary | 3.2-validation

In GOF_Mapping: Map simulation-observation pairs

PlotId | Project  | Simulation | Output       | ObservedData
-------|----------|------------|--------------|-------------
GOF-01 | Project1 | Sim1       | AUC          | Clinical-AUC
GOF-01 | Project1 | Sim2       | Cmax         | Clinical-Cmax
GOF-01 | Project2 | Sim3       | AUC          | Clinical-AUC

E. Configure Building Block Inheritance (BB sheet)

Add inheritance:

Project  | BB-Type    | BB-Name    | Parent-Project
---------|------------|------------|---------------
Project2 | Compound   | Drug-A     | Project1

Remove inheritance (leave Parent-Project empty):

Project  | BB-Type    | BB-Name    | Parent-Project
---------|------------|------------|---------------
Project2 | Compound   | Drug-A     | [empty]

F. Update Parameter Inheritance (SimParam sheet)

Specify parameter inheritance between simulations:

Project  | Parent Project | Parent Simulation | TargetSimulation | Path
---------|----------------|-------------------|------------------|-----
Project2 | Project1       | Sim-Control       | Sim-DDI          | Organism|*|Parameter

G. Add Building Block Documentation (Inputs sheet)

Include building block details in report:

Project  | BB-Type    | BB-Name      | Section Reference
---------|------------|--------------|------------------
Project1 | Compound   | Verapamil    | 2.1-compounds
Project1 | Individual | European-Pop | 2.2-populations

H. Adjust Plot Settings (GlobalPlotSettings and GlobalAxesSettings)

GlobalPlotSettings: Modify figure dimensions, fonts, resolution

GlobalAxesSettings: Change default units, scales, or dimension mappings

I. Update Schema Version (MetaInfo sheet)

If updating to work with a newer OSP Suite version:

Change from: 2.2
Change to:   2.3

Important: Only change this if you know the new version is compatible with your qualification framework.

Excel File Content

The Excel file contains all existing evaluations:

Excel Content

Qualification.plan.schema.version
3.3
Project Simulation Output
Mefenamic_acid PO MD 500 mg loading / 250 mg every 6 h Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood)
Mefenamic_acid PO SD 250 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood)
Mefenamic_acid PO SD 500 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood)
Dapagliflozin IV 0.08 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO SD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO SD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO SD 5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO SD 5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO SD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO SD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO SD 250 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO SD 250 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO SD 500 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO SD 500 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO SD 5 mg IC tablet (Chang 2015) (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO SD 250 mg fed (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO SD 250 mg fed (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO SD 10 mg IC tablet (Chang 2015) (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO MD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO MD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO MD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO MD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO MD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO MD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO MD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO MD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Dapagliflozin PO MD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Dapagliflozin PO MD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine
Raltegravir Raltegravir 800 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 10 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 100 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 1200 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 1600 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 200 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 25 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 50 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 400mg chewable fasted Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 400mg filmcoated tablet Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 400mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 100 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 200 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 400 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 400mg (granules in suspension) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Raltegravir Raltegravir 400mg chewable fed Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Atazanavir Acosta2007_300mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir Agarwala2003_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir Agarwala2005a_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir Agarwala2005b_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir Martin2008_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir Zhu2011_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungFemales Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-028_200mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-028_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-040_200mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-040_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-040_800mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-056_300mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-076_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-076_800mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir Zhu2010_300mg_Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-004_400mg_TreatmentA Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine
Atazanavir FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Mefenamic_acid-Dapagliflozin-DDI DDI Control - Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Mefenamic_acid-Dapagliflozin-DDI DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood)
Mefenamic_acid-Dapagliflozin-DDI DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood)
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood)
Project Simulation ObservedData
Mefenamic_acid PO SD 250 mg Rouini 2005 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12)
Mefenamic_acid PO SD 250 mg Mahadik 2012 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12)
Mefenamic_acid PO SD 250 mg Hamaguchi 1987 - Treatment 2 - fasted with 200 mL of water - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=4)
Mefenamic_acid PO SD 500 mg Goosen 2017 - 500 mg SD - Mefenamic acid - PO - 500 mg - Plasma - agg.
Dapagliflozin IV 0.08 mg (perm) Boulton 2013 - 14C-dapagliflozin iv - Dapagliflozin - IV - 0.08 mg - Plasma - agg. (n=7)
Dapagliflozin PO SD 10 mg (perm) Boulton 2013 - Dapagliflozin po - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=7)
Dapagliflozin PO SD 10 mg (perm) Imamura 2013 - Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=22)
Dapagliflozin PO SD 10 mg (perm) Kasichayanula 2011a - fasted - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14)
Dapagliflozin PO SD 10 mg (perm) Kasichayanula 2013a - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14)
Dapagliflozin PO SD 10 mg (perm) Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16)
Dapagliflozin PO SD 10 mg (perm) Vakkalagadda 2016 - Dapagliflozin - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=42)
Dapagliflozin PO SD 10 mg (perm) Kasichayanula 2011c - Healthy Volunteers - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 10 mg (perm) Komoroski 2009 - SAD 10 mg - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 10 mg (perm) Komoroski 2009 - SAD 10 mg (Urine) - Dapagliflozin - PO - 10 mg - Urine - agg. (n=6)
Dapagliflozin PO SD 10 mg (perm) Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 50 mg (perm) Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24)
Dapagliflozin PO SD 50 mg (perm) Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8)
Dapagliflozin PO SD 50 mg (perm) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6)
Dapagliflozin PO SD 50 mg (perm) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6)
Dapagliflozin PO SD 50 mg (perm) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6)
Dapagliflozin PO SD 50 mg (perm) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6)
Dapagliflozin PO SD 50 mg (perm) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6)
Dapagliflozin PO SD 50 mg (perm) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6)
Dapagliflozin PO SD 50 mg (perm) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6)
Dapagliflozin PO SD 50 mg (perm) Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 50 mg (perm) Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6)
Dapagliflozin PO SD 50 mg (perm) Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 2.5 mg (perm) Komoroski 2009 - SAD 2.5 mg - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 2.5 mg (perm) Komoroski 2009 - SAD 2.5 mg (Urine) - Dapagliflozin - PO - 2.5 mg - Urine - agg. (n=6)
Dapagliflozin PO SD 2.5 mg (perm) Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 5 mg (perm) Komoroski 2009 - SAD 5 mg - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 5 mg (perm) Komoroski 2009 - SAD 5 mg (Urine) - Dapagliflozin - PO - 5 mg - Urine - agg. (n=6)
Dapagliflozin PO SD 20 mg (perm) Kasichayanula 2012 - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=24)
Dapagliflozin PO SD 20 mg (perm) Komoroski 2009 - SAD 20 mg - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 20 mg (perm) Komoroski 2009 - SAD 20 mg (Urine) - Dapagliflozin - PO - 20 mg - Urine - agg. (n=6)
Dapagliflozin PO SD 20 mg (perm) Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 20 mg (perm) Kasichayanula 2011b - Study 2: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18)
Dapagliflozin PO SD 20 mg (perm) Kasichayanula 2011b - Study 3: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18)
Dapagliflozin PO SD 100 mg (perm) Komoroski 2009 - SAD 100 mg - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 100 mg (perm) Komoroski 2009 - SAD 100 mg (Urine) - Dapagliflozin - PO - 100 mg - Urine - agg. (n=6)
Dapagliflozin PO SD 100 mg (perm) Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 250 mg (perm) Komoroski 2009 - SAD 250 mg fasted - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 250 mg (perm) Komoroski 2009 - SAD 250 mg fasted (Urine) - Dapagliflozin - PO - 250 mg - Urine - agg. (n=6)
Dapagliflozin PO SD 500 mg (perm) Komoroski 2009 - SAD 500 mg - Dapagliflozin - PO - 500 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 500 mg (perm) Komoroski 2009 - SAD 500 mg (Urine) - Dapagliflozin - PO - 500 mg - Urine - agg. (n=6)
Dapagliflozin PO SD 5 mg IC tablet (Chang 2015) (perm) Chang 2015 - Study 1 Treatment A (single oral doses) - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=36)
Dapagliflozin PO SD 250 mg fed (perm) Komoroski 2009 - SAD 250 mg fed - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6)
Dapagliflozin PO SD 10 mg IC tablet (Chang 2015) (perm) Chang 2015 - Study 2 Treatment A (single oral doses) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=36)
Dapagliflozin PO MD 10 mg (perm) Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6)
Dapagliflozin PO MD 10 mg (perm) Komoroski 2009 - MAD 10 mg (day 7 and day 14) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6)
Dapagliflozin PO MD 100 mg (perm) Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6)
Dapagliflozin PO MD 100 mg (perm) Komoroski 2009 - MAD 100 mg (day 7 and day 14) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6)
Dapagliflozin PO MD 2.5 mg (perm) Komoroski 2009 - MAD 2.5 mg (day 7 and day 14) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6)
Dapagliflozin PO MD 2.5 mg (perm) Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6)
Dapagliflozin PO MD 20 mg (perm) Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6)
Dapagliflozin PO MD 20 mg (perm) Komoroski 2009 - MAD 20 mg (day 7 and day 14) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6)
Dapagliflozin PO MD 50 mg (perm) Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6)
Dapagliflozin PO MD 50 mg (perm) Komoroski 2009 - MAD 50 mg (day 7 and day 14) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6)
Raltegravir Raltegravir 800 mg (lactose formulation) Iwamoto 2008 - 800mg - Raltegravir - PO - 800 mg - Plasma - agg. (n=24)
Raltegravir Raltegravir 10 mg (lactose formulation) Iwamoto 2008 - 10mg - Raltegravir - PO - 10 mg - Plasma - agg. (n=24)
Raltegravir Raltegravir 100 mg (lactose formulation) Iwamoto 2008 - 100mg - Raltegravir - PO - 100 mg - Plasma - agg. (n=24)
Raltegravir Raltegravir 1200 mg (lactose formulation) Iwamoto 2008 - 1200mg - Raltegravir - PO - 1200 mg - Plasma - agg. (n=24)
Raltegravir Raltegravir 1600 mg (lactose formulation) Iwamoto 2008 - 1600mg - Raltegravir - PO - 1600 mg - Plasma - agg. (n=24)
Raltegravir Raltegravir 200 mg (lactose formulation) Iwamoto 2008 - 200mg - Raltegravir - PO - 200 mg - Plasma - agg. (n=24)
Raltegravir Raltegravir 25 mg (lactose formulation) Iwamoto 2008 - 25mg - Raltegravir - PO - 25 mg - Plasma - agg. (n=24)
Raltegravir Raltegravir 50 mg (lactose formulation) Iwamoto 2008 - 50mg - Raltegravir - PO - 50 mg - Plasma - agg. (n=24)
Raltegravir Raltegravir 400mg chewable fasted Rhee 2014 - Chewable tablet fasted - Raltegravir - po - 400 mg - Plasma - agg. (n=12)
Raltegravir Raltegravir 400mg filmcoated tablet Rhee 2014 - filmcoated tablet - Raltegravir - po - 400 mg - Plasma - agg. (n=12)
Raltegravir Raltegravir 400mg filmcoated tablet Wenning 2009 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=10)
Raltegravir Raltegravir 400mg filmcoated tablet Iwamoto 2008 - 400mg FCT - Raltegravir - PO - 400 mg - Plasma - agg. (n=14)
Raltegravir Raltegravir 400mg (lactose formulation) Iwamoto 2008 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=24)
Raltegravir Raltegravir 100 mg filmcoated tablet md Markowitz 2006 - 100mg FCT MD - Raltegravir - PO - 100 mg - Plasma - agg. (n=7)
Raltegravir Raltegravir 200 mg filmcoated tablet md Markowitz 2006 - 200mg FCT MD - Raltegravir - PO - 200 mg - Plasma - agg. (n=7)
Raltegravir Raltegravir 200 mg filmcoated tablet md Kassahun 2007 - 200mg FCT SD - Raltegravir - PO - 200 mg - Plasma - agg. (n=8)
Raltegravir Raltegravir 400 mg filmcoated tablet md Markowitz 2006 - 400mg FCT MD - Raltegravir - PO - 400 mg - Plasma - agg. (n=6)
Raltegravir Raltegravir 400mg (granules in suspension) Rhee 2014 - granules suspension - Raltegravir - po - 400 mg - Plasma - agg. (n=12)
Raltegravir Raltegravir 400mg chewable fed Rhee 2014 - Chewable tablet fed - Raltegravir - po - 400 mg - Plasma - agg. (n=12)
Atazanavir Acosta2007_300mg Acosta 2007 - Period 1 - Atazanavir - PO - 300 mg - Plasma - agg. (n=10)
Atazanavir Agarwala2003_400mg Agarwala 2003 - Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=65)
Atazanavir Agarwala2005a_400mg Agarwala 2005a - ATV 400 mg AM (N=15) - Atazanavir - PO - 400 mg - Plasma - agg. (n=15)
Atazanavir Agarwala2005b_400mg Agarwala 2005b - ATV 400 mg (Treatment A) - Atazanavir - PO - 400 mg - Plasma - agg. (n=16)
Atazanavir Martin2008_400mg Martin 2008 - Atazanavir monotherapy (n = 24) - Atazanavir - PO - 400 mg - Plasma - agg. (n=24)
Atazanavir Zhu2011_400mg Zhu 2011 - Treatment A: Atazanavir 400 mg QPM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28)
Atazanavir Zhu2011_400mg Zhu 2011 - Treatment B: Atazanavir 400 mg QAM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28)
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungFemales ClinPharmReview, AI424-014, p. 77 - Young Females - Atazanavir - PO - 400 mg - Plasma - agg. (n=14)
Atazanavir FDA-ClinPharmReview_AI424-028_200mg ClinPharmReview, AI424-028, p. 128 - A-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8)
Atazanavir FDA-ClinPharmReview_AI424-028_200mg ClinPharmReview, AI424-028, p. 128 - B-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8)
Atazanavir FDA-ClinPharmReview_AI424-028_400mg ClinPharmReview, AI424-028, p. 128 - C-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8)
Atazanavir FDA-ClinPharmReview_AI424-028_400mg ClinPharmReview, AI424-028, p. 128 - D-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8)
Atazanavir FDA-ClinPharmReview_AI424-040_200mg ClinPharmReview, AI424-040, p. 64 - 200 mg - Atazanavir - PO - 200 mg - Plasma - agg. (n=20)
Atazanavir FDA-ClinPharmReview_AI424-040_400mg ClinPharmReview, AI424-040, p. 64 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=20)
Atazanavir FDA-ClinPharmReview_AI424-040_800mg ClinPharmReview, AI424-040, p. 64 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=20)
Atazanavir FDA-ClinPharmReview_AI424-056_300mg ClinPharmReview, AI424-056, p. 134 - Atazanavir without ritonavir, Day 10 - Atazanavir - PO - 300 mg - Plasma - agg. (n=30)
Atazanavir FDA-ClinPharmReview_AI424-076_400mg ClinPharmReview, AI424-076, p. 178 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=65)
Atazanavir FDA-ClinPharmReview_AI424-076_800mg ClinPharmReview, AI424-076, p. 178 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=66)
Atazanavir Zhu2010_300mg_Atazanavir Zhu 2010 - Atazanvir 300 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=22)
Atazanavir FDA-ClinPharmReview_AI424-004_400mg_TreatmentA ClinPharmReview, AI424-004, p. 94 - Treatment A - Atazanavir - PO - 400 mg - Plasma - agg. (n=32)
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales ClinPharmReview, AI424-029, p. 47 - Urinary radioactivity - Atazanavir - PO - 400 - Urine - agg. (n=12)
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales ClinPharmReview, AI424-014, p. 77 - Young Males - Atazanavir - PO - 400 mg - Plasma - agg. (n=15)
Atazanavir FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects ClinPharmReview, AI424-015, p. 81 - Normal subjects - Atazanavir - PO - 400 mg - Plasma - agg. (n=16)
Mefenamic_acid-Dapagliflozin-DDI DDI Control - Dapagliflozin - Kasichayanula 2013a Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16)
Mefenamic_acid-Dapagliflozin-DDI DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a Kasichayanula 2013a - Study 2: with Perpetrator (Mefenamic Acid) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16)
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir Neely 2010 - Study arm A (Raltegravir 400mg BID) - Raltegravir - PO - 400 mg - Plasma - agg. (n=20)
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir+Atazanavir Neely 2010 - Study arm B (Raltegravir 400mg OD + Atazanavir 400 mg OD) - Raltegravir - PO - 400 mg - Plasma - agg. (n=19)
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir Iwamoto 2008 - Study I, Period 1 (control) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10)
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir+Atazanavir Iwamoto 2008 - Study I, Period 2 (ATV treatment) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10)
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir Krishna 2016 - Period 1, Day 1 (1200 mg raltegravir SD) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=14)
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir+Atazanavir Krishna 2016 - Period 2, Day 7 (1200 mg raltegravir SD with OD doses of 400 mg ATV) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=12)
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir Zhu 2010 - Raltegravir 400 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=22)
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Zhu 2010 - Raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=19)
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Zhu 2010 - Atazanvir 300 mg twice daily plus raltegravir 400 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=19)
Project BB-Type BB-Name Parent-Project
Mefenamic_acid-Dapagliflozin-DDI Individual Standard_Adult_UGT Dapagliflozin
Mefenamic_acid-Dapagliflozin-DDI Compound Mefenamic acid Mefenamic_acid
Mefenamic_acid-Dapagliflozin-DDI Compound Dapagliflozin Dapagliflozin
Mefenamic_acid-Dapagliflozin-DDI Formulation Ponstan capsule Mefenamic_acid
Atazanavir-Raltegravir-DDI Compound Raltegravir Raltegravir
Atazanavir-Raltegravir-DDI Compound Atazanavir Atazanavir
Atazanavir-Raltegravir-DDI Formulation Reyataz capsule Atazanavir
Atazanavir-Raltegravir-DDI Formulation filmcoated tablet (original Merck formulation) Raltegravir
Mefenamic_acid Individual Standard_Adult
Mefenamic_acid Compound Mefenamic acid
Mefenamic_acid Protocol PO MD 500 mg loading / 250 mg every 6 h
Mefenamic_acid Protocol 250 mg SD
Mefenamic_acid Protocol 500 mg SD
Mefenamic_acid Event breakfast
Mefenamic_acid Event snack (MEFA)
Mefenamic_acid Formulation Ponstan capsule
Dapagliflozin Individual Standard_Adult_UGT
Dapagliflozin Compound Dapagliflozin
Dapagliflozin Protocol IV 0.08 mg
Dapagliflozin Protocol PO SD 50 mg
Dapagliflozin Protocol PO SD 2.5 mg
Dapagliflozin Protocol PO SD 5 mg
Dapagliflozin Protocol PO SD 10 mg
Dapagliflozin Protocol PO SD 20 mg
Dapagliflozin Protocol PO SD 100 mg
Dapagliflozin Protocol PO SD 250 mg
Dapagliflozin Protocol PO SD 500 mg
Dapagliflozin Protocol PO MD 2.5 mg
Dapagliflozin Protocol PO MD 10 mg
Dapagliflozin Protocol PO MD 20 mg
Dapagliflozin Protocol PO MD 50 mg
Dapagliflozin Protocol PO MD 100 mg
Dapagliflozin Event breakfast
Dapagliflozin Formulation Dissolved
Dapagliflozin Formulation IC tablet (Chang 2015)
Raltegravir Individual Standard European Male for PEQ
Raltegravir Compound Raltegravir
Raltegravir Protocol Iwamoto 2008 400mg PO (Figure 1) omeprazole study
Raltegravir Protocol Iwamoto 2008 10mg PO (Figure 2) Safety-Tolerability-PK study
Raltegravir Protocol Iwamoto 2008 25mg PO (Figure 2) Safety-Tolerability-PK study
Raltegravir Protocol Iwamoto 2008 50mg PO (Figure 2) Safety-Tolerability-PK study
Raltegravir Protocol Iwamoto 2008 100mg PO (Figure 2) Safety-Tolerability-PK study
Raltegravir Protocol Iwamoto 2008 200mg PO (Figure 2) Safety-Tolerability-PK study
Raltegravir Protocol Iwamoto 2008 800mg PO (Figure 2) Safety-Tolerability-PK study
Raltegravir Protocol Iwamoto 2008 1200mg PO (Figure 2) Safety-Tolerability-PK study
Raltegravir Protocol Iwamoto 2008 1600mg PO (Figure 2) Safety-Tolerability-PK study
Raltegravir Protocol Markowitz 2006 100mg bid 10d
Raltegravir Protocol Markowitz 2006 200mg bid 10d
Raltegravir Protocol Markowitz 2006 400mg bid 10d
Raltegravir Event Food
Raltegravir Formulation Weibull (lactose formulation)
Raltegravir Formulation chewable tablet
Raltegravir Formulation filmcoated tablet (original Merck formulation)
Raltegravir Formulation Weibull (granules)
Atazanavir Individual Agarwala2003
Atazanavir Individual Agarwala2005a
Atazanavir Individual Agarwala2005b
Atazanavir Individual Martin2008
Atazanavir Individual Zhu2011
Atazanavir Individual WhiteAmericanMale
Atazanavir Individual WhiteAmericanFemale
Atazanavir Individual Zhu2010
Atazanavir Individual Acosta2007
Atazanavir Compound Atazanavir
Atazanavir Protocol 400mg_QD_7days
Atazanavir Protocol 400mg_QD_6days
Atazanavir Protocol 400mg_QD_5days
Atazanavir Protocol 200mg_QD_5days
Atazanavir Protocol 800mg_QD_5days
Atazanavir Protocol 400mg_SD
Atazanavir Protocol 300mg_BID_7days_at120h
Atazanavir Protocol 300mg_BID
Atazanavir Protocol 200mg_QD_6days
Atazanavir Protocol 300mg_QD_10days
Atazanavir Protocol 800mg_QD_6days
Atazanavir Event High-fat breakfast
Atazanavir Event Light meal
Atazanavir Formulation Reyataz capsule
Mefenamic_acid-Dapagliflozin-DDI Protocol Dapagliflozin - PO SD 10 mg
Mefenamic_acid-Dapagliflozin-DDI Protocol Mefenamic acid - PO MD 500 mg loading / 250 mg every 6 h
Mefenamic_acid-Dapagliflozin-DDI Protocol Dapagliflozin - PO SD 10 mg (with MEFA)
Mefenamic_acid-Dapagliflozin-DDI Event snack (MEFA)
Mefenamic_acid-Dapagliflozin-DDI Formulation Solution
Atazanavir-Raltegravir-DDI Individual Neely2010
Atazanavir-Raltegravir-DDI Individual HispanicMale
Atazanavir-Raltegravir-DDI Individual Krishna2016
Atazanavir-Raltegravir-DDI Individual Zhu2010
Atazanavir-Raltegravir-DDI Protocol 400mg_BID_8days
Atazanavir-Raltegravir-DDI Protocol Raltegravir_400mg_QD_8days
Atazanavir-Raltegravir-DDI Protocol Raltegravir_100mg_at144h
Atazanavir-Raltegravir-DDI Protocol Raltegravir_100mg
Atazanavir-Raltegravir-DDI Protocol Raltegravir_1200mg
Atazanavir-Raltegravir-DDI Protocol Raltegravir_1200mg_at144h
Atazanavir-Raltegravir-DDI Protocol Raltegravir_400mg_BID_5days
Atazanavir-Raltegravir-DDI Protocol Raltegravir_400mg_BID_14days_at288h
Atazanavir-Raltegravir-DDI Protocol 300mg_BID_14days_at288h
Atazanavir-Raltegravir-DDI Protocol 400mg_QD_9days
Atazanavir-Raltegravir-DDI Protocol 400mg_QD_8days
Atazanavir-Raltegravir-DDI Event High-fat breakfast
Atazanavir-Raltegravir-DDI Event Light meal
Project Parent.Project Parent.Simulation Path TargetSimulation
Mefenamic_acid-Dapagliflozin-DDI Dapagliflozin PO SD 10 mg (perm) Dapagliflozin|logP (veg.oil/water) DDI Control - Dapagliflozin - Kasichayanula 2013a
Mefenamic_acid-Dapagliflozin-DDI Dapagliflozin PO SD 10 mg (perm) Dapagliflozin|logP (veg.oil/water) DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a
Mefenamic_acid-Dapagliflozin-DDI Dapagliflozin PO SD 10 mg (perm) Dapagliflozin|Blood/Plasma concentration ratio DDI Control - Dapagliflozin - Kasichayanula 2013a
Mefenamic_acid-Dapagliflozin-DDI Dapagliflozin PO SD 10 mg (perm) Dapagliflozin|Blood/Plasma concentration ratio DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a
Project Simulation Section.Reference
Raltegravir tralala introduction
Mefenamic_acid PO MD 500 mg loading / 250 mg every 6 h NA
Mefenamic_acid PO SD 250 mg NA
Mefenamic_acid PO SD 500 mg NA
Dapagliflozin IV 0.08 mg (perm) NA
Dapagliflozin PO SD 10 mg (perm) NA
Dapagliflozin PO SD 10 mg (perm) NA
Dapagliflozin PO SD 50 mg (perm) NA
Dapagliflozin PO SD 50 mg (perm) NA
Dapagliflozin PO SD 50 mg (perm) NA
Dapagliflozin PO SD 50 mg (perm) NA
Dapagliflozin PO SD 50 mg (perm) NA
Dapagliflozin PO SD 50 mg (perm) NA
Dapagliflozin PO SD 2.5 mg (perm) NA
Dapagliflozin PO SD 2.5 mg (perm) NA
Dapagliflozin PO SD 5 mg (perm) NA
Dapagliflozin PO SD 5 mg (perm) NA
Dapagliflozin PO SD 20 mg (perm) NA
Dapagliflozin PO SD 20 mg (perm) NA
Dapagliflozin PO SD 100 mg (perm) NA
Dapagliflozin PO SD 100 mg (perm) NA
Dapagliflozin PO SD 250 mg (perm) NA
Dapagliflozin PO SD 250 mg (perm) NA
Dapagliflozin PO SD 500 mg (perm) NA
Dapagliflozin PO SD 500 mg (perm) NA
Dapagliflozin PO SD 5 mg IC tablet (Chang 2015) (perm) NA
Dapagliflozin PO SD 250 mg fed (perm) NA
Dapagliflozin PO SD 250 mg fed (perm) NA
Dapagliflozin PO SD 10 mg IC tablet (Chang 2015) (perm) NA
Dapagliflozin PO MD 10 mg (perm) NA
Dapagliflozin PO MD 10 mg (perm) NA
Dapagliflozin PO MD 100 mg (perm) NA
Dapagliflozin PO MD 100 mg (perm) NA
Dapagliflozin PO MD 2.5 mg (perm) NA
Dapagliflozin PO MD 2.5 mg (perm) NA
Dapagliflozin PO MD 20 mg (perm) NA
Dapagliflozin PO MD 20 mg (perm) NA
Dapagliflozin PO MD 50 mg (perm) NA
Dapagliflozin PO MD 50 mg (perm) NA
Raltegravir Raltegravir 800 mg (lactose formulation) NA
Raltegravir Raltegravir 10 mg (lactose formulation) NA
Raltegravir Raltegravir 100 mg (lactose formulation) NA
Raltegravir Raltegravir 1200 mg (lactose formulation) NA
Raltegravir Raltegravir 1600 mg (lactose formulation) NA
Raltegravir Raltegravir 200 mg (lactose formulation) NA
Raltegravir Raltegravir 25 mg (lactose formulation) NA
Raltegravir Raltegravir 50 mg (lactose formulation) NA
Raltegravir Raltegravir 400mg chewable fasted NA
Raltegravir Raltegravir 400mg filmcoated tablet NA
Raltegravir Raltegravir 400mg (lactose formulation) NA
Raltegravir Raltegravir 100 mg filmcoated tablet md NA
Raltegravir Raltegravir 200 mg filmcoated tablet md NA
Raltegravir Raltegravir 400 mg filmcoated tablet md NA
Raltegravir Raltegravir 400mg (granules in suspension) NA
Raltegravir Raltegravir 400mg chewable fed NA
Atazanavir Acosta2007_300mg NA
Atazanavir Agarwala2003_400mg NA
Atazanavir Agarwala2005a_400mg NA
Atazanavir Agarwala2005b_400mg NA
Atazanavir Martin2008_400mg NA
Atazanavir Zhu2011_400mg NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungFemales NA
Atazanavir FDA-ClinPharmReview_AI424-028_200mg NA
Atazanavir FDA-ClinPharmReview_AI424-028_400mg NA
Atazanavir FDA-ClinPharmReview_AI424-040_200mg NA
Atazanavir FDA-ClinPharmReview_AI424-040_400mg NA
Atazanavir FDA-ClinPharmReview_AI424-040_800mg NA
Atazanavir FDA-ClinPharmReview_AI424-056_300mg NA
Atazanavir FDA-ClinPharmReview_AI424-076_400mg NA
Atazanavir FDA-ClinPharmReview_AI424-076_800mg NA
Atazanavir Zhu2010_300mg_Atazanavir NA
Atazanavir FDA-ClinPharmReview_AI424-004_400mg_TreatmentA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales NA
Atazanavir FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects NA
Mefenamic_acid-Dapagliflozin-DDI DDI Control - Dapagliflozin - Kasichayanula 2013a NA
Mefenamic_acid-Dapagliflozin-DDI DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a NA
Mefenamic_acid-Dapagliflozin-DDI DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a NA
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir NA
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir+Atazanavir NA
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir+Atazanavir NA
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir NA
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir+Atazanavir NA
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir+Atazanavir NA
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir NA
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir+Atazanavir NA
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir+Atazanavir NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir NA
Title Section.Reference Simulation.Duration TimeUnit ChartWidth ChartHeight AxisSize LegendSize OriginSize FontFamilyName WatermarkSize X_Dimension X_GridLines X_Scaling Y_Dimension Y_GridLines Y_Scaling
Iwamoto 2008 atazanavir-raltegravir-ddi 176 h NA NA NA NA NA NA NA NA NA NA NA NA NA
Krishna 2016 atazanavir-raltegravir-ddi 216 h NA NA NA NA NA NA NA NA NA NA NA NA NA
Neely 2010 atazanavir-raltegravir-ddi 192 h NA NA NA NA NA NA NA NA NA NA NA NA NA
Zhu 2010 atazanavir-raltegravir-ddi 612 h NA NA NA NA NA NA NA NA NA NA NA NA NA
Kasichayanula 2013a mefenamic-acid-dapagliflozin-ddi 48 h NA NA NA NA NA NA NA NA NA NA NA NA NA
Project Simulation Output Observed.data Plot.Title StartTime TimeUnit Color Caption Symbol
Atazanavir Acosta2007_300mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Acosta 2007 - Period 1 - Atazanavir - PO - 300 mg - Plasma - agg. (n=10) NA NA NA NA NA NA
Atazanavir Agarwala2003_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Agarwala 2003 - Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=65) NA NA NA NA NA NA
Atazanavir Agarwala2005a_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Agarwala 2005a - ATV 400 mg AM (N=15) - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) NA NA NA NA NA NA
Atazanavir Agarwala2005b_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Agarwala 2005b - ATV 400 mg (Treatment A) - Atazanavir - PO - 400 mg - Plasma - agg. (n=16) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-004_400mg_TreatmentA Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-004, p. 94 - Treatment A - Atazanavir - PO - 400 mg - Plasma - agg. (n=32) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungFemales Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-014, p. 77 - Young Females - Atazanavir - PO - 400 mg - Plasma - agg. (n=14) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine ClinPharmReview, AI424-014, p. 77 - Young Males - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine ClinPharmReview, AI424-029, p. 47 - Urinary radioactivity - Atazanavir - PO - 400 - Urine - agg. (n=12) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-014, p. 77 - Young Males - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-029, p. 47 - Urinary radioactivity - Atazanavir - PO - 400 - Urine - agg. (n=12) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-015, p. 81 - Normal subjects - Atazanavir - PO - 400 mg - Plasma - agg. (n=16) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-028_200mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-028, p. 128 - A-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-028_200mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-028, p. 128 - B-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-028_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-028, p. 128 - C-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-028_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-028, p. 128 - D-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-040_200mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-040, p. 64 - 200 mg - Atazanavir - PO - 200 mg - Plasma - agg. (n=20) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-040_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-040, p. 64 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=20) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-040_800mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-040, p. 64 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=20) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-056_300mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-056, p. 134 - Atazanavir without ritonavir, Day 10 - Atazanavir - PO - 300 mg - Plasma - agg. (n=30) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-076_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-076, p. 178 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=65) NA NA NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-076_800mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-076, p. 178 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=66) NA NA NA NA NA NA
Atazanavir Martin2008_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Martin 2008 - Atazanavir monotherapy (n = 24) - Atazanavir - PO - 400 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Atazanavir Zhu2010_300mg_Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Zhu 2010 - Atazanvir 300 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=22) NA NA NA NA NA NA
Atazanavir Zhu2011_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Zhu 2011 - Treatment A: Atazanavir 400 mg QPM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28) NA NA NA NA NA NA
Atazanavir Zhu2011_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Zhu 2011 - Treatment B: Atazanavir 400 mg QAM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28) NA NA NA NA NA NA
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - Study I, Period 1 (control) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) Iwamoto 2008 0 h #2166ac Control (without atazanavir) Circle
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - Study I, Period 2 (ATV treatment) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) NA NA NA NA NA NA
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - Study I, Period 2 (ATV treatment) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) Iwamoto 2008 144 h #b2182b Treatment (with atazanavir) Square
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Krishna 2016 - Period 1, Day 1 (1200 mg raltegravir SD) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=14) Krishna 2016 0 h #2166ac Control (without atazanavir) Circle
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Krishna 2016 - Period 2, Day 7 (1200 mg raltegravir SD with OD doses of 400 mg ATV) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=12) NA NA NA NA NA NA
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Krishna 2016 - Period 2, Day 7 (1200 mg raltegravir SD with OD doses of 400 mg ATV) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=12) Krishna 2016 144 h #b2182b Treatment (with atazanavir) Square
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Neely 2010 - Study arm A (Raltegravir 400mg BID) - Raltegravir - PO - 400 mg - Plasma - agg. (n=20) Neely 2010 168 h #2166ac Control (without atazanavir) Circle
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Neely 2010 - Study arm B (Raltegravir 400mg OD + Atazanavir 400 mg OD) - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) NA NA NA NA NA NA
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Neely 2010 - Study arm B (Raltegravir 400mg OD + Atazanavir 400 mg OD) - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) Neely 2010 168 h #b2182b Treatment (with atazanavir) Square
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Zhu 2010 - Raltegravir 400 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=22) Zhu 2010 96 h #2166ac Control (without atazanavir) Circle
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Zhu 2010 - Atazanvir 300 mg twice daily plus raltegravir 400 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=19) NA NA NA NA NA NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Zhu 2010 - Raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) NA NA NA NA NA NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Zhu 2010 - Atazanvir 300 mg twice daily plus raltegravir 400 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=19) NA NA NA NA NA NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Zhu 2010 - Raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) Zhu 2010 600 h #b2182b Treatment (with atazanavir) Square
Dapagliflozin IV 0.08 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Boulton 2013 - 14C-dapagliflozin iv - Dapagliflozin - IV - 0.08 mg - Plasma - agg. (n=7) NA NA NA NA NA NA
Dapagliflozin PO MD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 10 mg (day 7 and day 14) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 10 mg (day 7 and day 14) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 100 mg (day 7 and day 14) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 100 mg (day 7 and day 14) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 2.5 mg (day 7 and day 14) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 2.5 mg (day 7 and day 14) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 20 mg (day 7 and day 14) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 20 mg (day 7 and day 14) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 50 mg (day 7 and day 14) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO MD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 50 mg (day 7 and day 14) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Boulton 2013 - Dapagliflozin po - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=7) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Imamura 2013 - Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=22) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2011a - fasted - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2011c - Healthy Volunteers - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2013a - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 10 mg (Urine) - Dapagliflozin - PO - 10 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 10 mg - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Vakkalagadda 2016 - Dapagliflozin - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=42) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Boulton 2013 - Dapagliflozin po - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=7) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Imamura 2013 - Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=22) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2011a - fasted - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2011c - Healthy Volunteers - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2013a - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 10 mg (Urine) - Dapagliflozin - PO - 10 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 10 mg - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Vakkalagadda 2016 - Dapagliflozin - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=42) NA NA NA NA NA NA
Dapagliflozin PO SD 10 mg IC tablet (Chang 2015) (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Chang 2015 - Study 2 Treatment A (single oral doses) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=36) NA NA NA NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 100 mg (Urine) - Dapagliflozin - PO - 100 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 100 mg - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 100 mg (Urine) - Dapagliflozin - PO - 100 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 100 mg - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 2.5 mg (Urine) - Dapagliflozin - PO - 2.5 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 2.5 mg - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 2.5 mg (Urine) - Dapagliflozin - PO - 2.5 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 2.5 mg - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2011b - Study 2: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2011b - Study 3: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2012 - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 20 mg (Urine) - Dapagliflozin - PO - 20 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 20 mg - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2011b - Study 2: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2011b - Study 3: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2012 - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 20 mg (Urine) - Dapagliflozin - PO - 20 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 20 mg - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 250 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 250 mg fasted (Urine) - Dapagliflozin - PO - 250 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 250 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 250 mg fasted - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 250 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 250 mg fasted (Urine) - Dapagliflozin - PO - 250 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 250 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 250 mg fasted - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 250 mg fed (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 250 mg fed - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 250 mg fed (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 250 mg fed - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 5 mg (Urine) - Dapagliflozin - PO - 5 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 5 mg - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 5 mg (Urine) - Dapagliflozin - PO - 5 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 5 mg - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 5 mg IC tablet (Chang 2015) (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Chang 2015 - Study 1 Treatment A (single oral doses) - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=36) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 500 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 500 mg (Urine) - Dapagliflozin - PO - 500 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 500 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 500 mg - Dapagliflozin - PO - 500 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 500 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 500 mg (Urine) - Dapagliflozin - PO - 500 mg - Urine - agg. (n=6) NA NA NA NA NA NA
Dapagliflozin PO SD 500 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 500 mg - Dapagliflozin - PO - 500 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Mefenamic_acid PO MD 500 mg loading / 250 mg every 6 h Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) NA NA NA NA NA NA NA
Mefenamic_acid PO SD 250 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) Hamaguchi 1987 - Treatment 2 - fasted with 200 mL of water - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=4) NA NA NA NA NA NA
Mefenamic_acid PO SD 250 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) Mahadik 2012 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12) NA NA NA NA NA NA
Mefenamic_acid PO SD 250 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) Rouini 2005 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12) NA NA NA NA NA NA
Mefenamic_acid PO SD 500 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) Goosen 2017 - 500 mg SD - Mefenamic acid - PO - 500 mg - Plasma - agg. NA NA NA NA NA NA
Mefenamic_acid-Dapagliflozin-DDI DDI Control - Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) Kasichayanula 2013a 0 h #2166ac Control (without mefenamic acid) Circle
Mefenamic_acid-Dapagliflozin-DDI DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2013a - Study 2: with Perpetrator (Mefenamic Acid) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) Kasichayanula 2013a 24 h #b2182b Treatment (with mefenamic acid) Square
Mefenamic_acid-Dapagliflozin-DDI DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) Kasichayanula 2013a - Study 2: with Perpetrator (Mefenamic Acid) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) NA NA NA NA NA NA
Raltegravir Raltegravir 10 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 10mg - Raltegravir - PO - 10 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Raltegravir Raltegravir 100 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 100mg - Raltegravir - PO - 100 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Raltegravir Raltegravir 100 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Markowitz 2006 - 100mg FCT MD - Raltegravir - PO - 100 mg - Plasma - agg. (n=7) NA NA NA NA NA NA
Raltegravir Raltegravir 1200 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 1200mg - Raltegravir - PO - 1200 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Raltegravir Raltegravir 1600 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 1600mg - Raltegravir - PO - 1600 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Raltegravir Raltegravir 200 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 200mg - Raltegravir - PO - 200 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Raltegravir Raltegravir 200 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Kassahun 2007 - 200mg FCT SD - Raltegravir - PO - 200 mg - Plasma - agg. (n=8) NA NA NA NA NA NA
Raltegravir Raltegravir 200 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Markowitz 2006 - 200mg FCT MD - Raltegravir - PO - 200 mg - Plasma - agg. (n=7) NA NA NA NA NA NA
Raltegravir Raltegravir 25 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 25mg - Raltegravir - PO - 25 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Raltegravir Raltegravir 400 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Markowitz 2006 - 400mg FCT MD - Raltegravir - PO - 400 mg - Plasma - agg. (n=6) NA NA NA NA NA NA
Raltegravir Raltegravir 400mg (granules in suspension) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Rhee 2014 - granules suspension - Raltegravir - po - 400 mg - Plasma - agg. (n=12) NA NA NA NA NA NA
Raltegravir Raltegravir 400mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Raltegravir Raltegravir 400mg chewable fasted Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Rhee 2014 - Chewable tablet fasted - Raltegravir - po - 400 mg - Plasma - agg. (n=12) NA NA NA NA NA NA
Raltegravir Raltegravir 400mg chewable fed Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Rhee 2014 - Chewable tablet fed - Raltegravir - po - 400 mg - Plasma - agg. (n=12) NA NA NA NA NA NA
Raltegravir Raltegravir 400mg filmcoated tablet Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 400mg FCT - Raltegravir - PO - 400 mg - Plasma - agg. (n=14) NA NA NA NA NA NA
Raltegravir Raltegravir 400mg filmcoated tablet Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Rhee 2014 - filmcoated tablet - Raltegravir - po - 400 mg - Plasma - agg. (n=12) NA NA NA NA NA NA
Raltegravir Raltegravir 400mg filmcoated tablet Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Wenning 2009 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=10) NA NA NA NA NA NA
Raltegravir Raltegravir 50 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 50mg - Raltegravir - PO - 50 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Raltegravir Raltegravir 800 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 800mg - Raltegravir - PO - 800 mg - Plasma - agg. (n=24) NA NA NA NA NA NA
Title Section.Reference Plot.Type Artifacts Group.Caption Group.Symbol ChartWidth ChartHeight AxisSize LegendSize OriginSize FontFamilyName WatermarkSize X_Dimension X_GridLines X_Scaling Y_Dimension Y_GridLines Y_Scaling
Project Simulation Output Observed.data Plot.Title Group.Title Color
Atazanavir Acosta2007_300mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Acosta 2007 - Period 1 - Atazanavir - PO - 300 mg - Plasma - agg. (n=10) NA NA NA
Atazanavir Agarwala2003_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Agarwala 2003 - Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=65) NA NA NA
Atazanavir Agarwala2005a_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Agarwala 2005a - ATV 400 mg AM (N=15) - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) NA NA NA
Atazanavir Agarwala2005b_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Agarwala 2005b - ATV 400 mg (Treatment A) - Atazanavir - PO - 400 mg - Plasma - agg. (n=16) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-004_400mg_TreatmentA Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-004, p. 94 - Treatment A - Atazanavir - PO - 400 mg - Plasma - agg. (n=32) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungFemales Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-014, p. 77 - Young Females - Atazanavir - PO - 400 mg - Plasma - agg. (n=14) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine ClinPharmReview, AI424-014, p. 77 - Young Males - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine ClinPharmReview, AI424-029, p. 47 - Urinary radioactivity - Atazanavir - PO - 400 - Urine - agg. (n=12) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-014, p. 77 - Young Males - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-029, p. 47 - Urinary radioactivity - Atazanavir - PO - 400 - Urine - agg. (n=12) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-015, p. 81 - Normal subjects - Atazanavir - PO - 400 mg - Plasma - agg. (n=16) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-028_200mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-028, p. 128 - A-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-028_200mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-028, p. 128 - B-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-028_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-028, p. 128 - C-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-028_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-028, p. 128 - D-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-040_200mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-040, p. 64 - 200 mg - Atazanavir - PO - 200 mg - Plasma - agg. (n=20) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-040_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-040, p. 64 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=20) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-040_800mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-040, p. 64 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=20) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-056_300mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-056, p. 134 - Atazanavir without ritonavir, Day 10 - Atazanavir - PO - 300 mg - Plasma - agg. (n=30) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-076_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-076, p. 178 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=65) NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-076_800mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) ClinPharmReview, AI424-076, p. 178 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=66) NA NA NA
Atazanavir Martin2008_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Martin 2008 - Atazanavir monotherapy (n = 24) - Atazanavir - PO - 400 mg - Plasma - agg. (n=24) NA NA NA
Atazanavir Zhu2010_300mg_Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Zhu 2010 - Atazanvir 300 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=22) NA NA NA
Atazanavir Zhu2011_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Zhu 2011 - Treatment A: Atazanavir 400 mg QPM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28) NA NA NA
Atazanavir Zhu2011_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Zhu 2011 - Treatment B: Atazanavir 400 mg QAM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28) NA NA NA
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - Study I, Period 1 (control) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) NA NA NA
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - Study I, Period 2 (ATV treatment) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) NA NA NA
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - Study I, Period 2 (ATV treatment) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) NA NA NA
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Krishna 2016 - Period 1, Day 1 (1200 mg raltegravir SD) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=14) NA NA NA
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Krishna 2016 - Period 2, Day 7 (1200 mg raltegravir SD with OD doses of 400 mg ATV) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=12) NA NA NA
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Krishna 2016 - Period 2, Day 7 (1200 mg raltegravir SD with OD doses of 400 mg ATV) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=12) NA NA NA
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Neely 2010 - Study arm A (Raltegravir 400mg BID) - Raltegravir - PO - 400 mg - Plasma - agg. (n=20) NA NA NA
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Neely 2010 - Study arm B (Raltegravir 400mg OD + Atazanavir 400 mg OD) - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) NA NA NA
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Neely 2010 - Study arm B (Raltegravir 400mg OD + Atazanavir 400 mg OD) - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) NA NA NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Zhu 2010 - Raltegravir 400 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=22) NA NA NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Zhu 2010 - Atazanvir 300 mg twice daily plus raltegravir 400 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=19) NA NA NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) Zhu 2010 - Raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) NA NA NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Zhu 2010 - Atazanvir 300 mg twice daily plus raltegravir 400 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=19) NA NA NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Zhu 2010 - Raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) NA NA NA
Dapagliflozin IV 0.08 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Boulton 2013 - 14C-dapagliflozin iv - Dapagliflozin - IV - 0.08 mg - Plasma - agg. (n=7) NA NA NA
Dapagliflozin PO MD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 10 mg (day 7 and day 14) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 10 mg (day 7 and day 14) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 100 mg (day 7 and day 14) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 100 mg (day 7 and day 14) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 2.5 mg (day 7 and day 14) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 2.5 mg (day 7 and day 14) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 20 mg (day 7 and day 14) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 20 mg (day 7 and day 14) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 50 mg (day 7 and day 14) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO MD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 50 mg (day 7 and day 14) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Boulton 2013 - Dapagliflozin po - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=7) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Imamura 2013 - Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=22) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2011a - fasted - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2011c - Healthy Volunteers - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2013a - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 10 mg (Urine) - Dapagliflozin - PO - 10 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 10 mg - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Vakkalagadda 2016 - Dapagliflozin - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=42) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Boulton 2013 - Dapagliflozin po - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=7) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Imamura 2013 - Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=22) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2011a - fasted - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2011c - Healthy Volunteers - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2013a - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 10 mg (Urine) - Dapagliflozin - PO - 10 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 10 mg - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Vakkalagadda 2016 - Dapagliflozin - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=42) NA NA NA
Dapagliflozin PO SD 10 mg IC tablet (Chang 2015) (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Chang 2015 - Study 2 Treatment A (single oral doses) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=36) NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 100 mg (Urine) - Dapagliflozin - PO - 100 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 100 mg - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 100 mg (Urine) - Dapagliflozin - PO - 100 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 100 mg - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 2.5 mg (Urine) - Dapagliflozin - PO - 2.5 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 2.5 mg - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 2.5 mg (Urine) - Dapagliflozin - PO - 2.5 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 2.5 mg - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2011b - Study 2: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2011b - Study 3: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2012 - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=24) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 20 mg (Urine) - Dapagliflozin - PO - 20 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 20 mg - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2011b - Study 2: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2011b - Study 3: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2012 - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=24) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 20 mg (Urine) - Dapagliflozin - PO - 20 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 20 mg - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 250 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 250 mg fasted (Urine) - Dapagliflozin - PO - 250 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 250 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 250 mg fasted - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 250 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 250 mg fasted (Urine) - Dapagliflozin - PO - 250 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 250 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 250 mg fasted - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 250 mg fed (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 250 mg fed - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 250 mg fed (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 250 mg fed - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 5 mg (Urine) - Dapagliflozin - PO - 5 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 5 mg - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 5 mg (Urine) - Dapagliflozin - PO - 5 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 5 mg - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 5 mg IC tablet (Chang 2015) (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Chang 2015 - Study 1 Treatment A (single oral doses) - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=36) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 500 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 500 mg (Urine) - Dapagliflozin - PO - 500 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 500 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine Komoroski 2009 - SAD 500 mg - Dapagliflozin - PO - 500 mg - Plasma - agg. (n=6) NA NA NA
Dapagliflozin PO SD 500 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 500 mg (Urine) - Dapagliflozin - PO - 500 mg - Urine - agg. (n=6) NA NA NA
Dapagliflozin PO SD 500 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Komoroski 2009 - SAD 500 mg - Dapagliflozin - PO - 500 mg - Plasma - agg. (n=6) NA NA NA
Mefenamic_acid PO MD 500 mg loading / 250 mg every 6 h Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) NA NA NA NA
Mefenamic_acid PO SD 250 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) Hamaguchi 1987 - Treatment 2 - fasted with 200 mL of water - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=4) NA NA NA
Mefenamic_acid PO SD 250 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) Mahadik 2012 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12) NA NA NA
Mefenamic_acid PO SD 250 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) Rouini 2005 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12) NA NA NA
Mefenamic_acid PO SD 500 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) Goosen 2017 - 500 mg SD - Mefenamic acid - PO - 500 mg - Plasma - agg. NA NA NA
Mefenamic_acid-Dapagliflozin-DDI DDI Control - Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) NA NA NA
Mefenamic_acid-Dapagliflozin-DDI DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) Kasichayanula 2013a - Study 2: with Perpetrator (Mefenamic Acid) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) NA NA NA
Mefenamic_acid-Dapagliflozin-DDI DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) Kasichayanula 2013a - Study 2: with Perpetrator (Mefenamic Acid) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) NA NA NA
Raltegravir Raltegravir 10 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 10mg - Raltegravir - PO - 10 mg - Plasma - agg. (n=24) NA NA NA
Raltegravir Raltegravir 100 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 100mg - Raltegravir - PO - 100 mg - Plasma - agg. (n=24) NA NA NA
Raltegravir Raltegravir 100 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Markowitz 2006 - 100mg FCT MD - Raltegravir - PO - 100 mg - Plasma - agg. (n=7) NA NA NA
Raltegravir Raltegravir 1200 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 1200mg - Raltegravir - PO - 1200 mg - Plasma - agg. (n=24) NA NA NA
Raltegravir Raltegravir 1600 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 1600mg - Raltegravir - PO - 1600 mg - Plasma - agg. (n=24) NA NA NA
Raltegravir Raltegravir 200 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 200mg - Raltegravir - PO - 200 mg - Plasma - agg. (n=24) NA NA NA
Raltegravir Raltegravir 200 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Kassahun 2007 - 200mg FCT SD - Raltegravir - PO - 200 mg - Plasma - agg. (n=8) NA NA NA
Raltegravir Raltegravir 200 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Markowitz 2006 - 200mg FCT MD - Raltegravir - PO - 200 mg - Plasma - agg. (n=7) NA NA NA
Raltegravir Raltegravir 25 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 25mg - Raltegravir - PO - 25 mg - Plasma - agg. (n=24) NA NA NA
Raltegravir Raltegravir 400 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Markowitz 2006 - 400mg FCT MD - Raltegravir - PO - 400 mg - Plasma - agg. (n=6) NA NA NA
Raltegravir Raltegravir 400mg (granules in suspension) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Rhee 2014 - granules suspension - Raltegravir - po - 400 mg - Plasma - agg. (n=12) NA NA NA
Raltegravir Raltegravir 400mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=24) NA NA NA
Raltegravir Raltegravir 400mg chewable fasted Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Rhee 2014 - Chewable tablet fasted - Raltegravir - po - 400 mg - Plasma - agg. (n=12) NA NA NA
Raltegravir Raltegravir 400mg chewable fed Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Rhee 2014 - Chewable tablet fed - Raltegravir - po - 400 mg - Plasma - agg. (n=12) NA NA NA
Raltegravir Raltegravir 400mg filmcoated tablet Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 400mg FCT - Raltegravir - PO - 400 mg - Plasma - agg. (n=14) NA NA NA
Raltegravir Raltegravir 400mg filmcoated tablet Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Rhee 2014 - filmcoated tablet - Raltegravir - po - 400 mg - Plasma - agg. (n=12) NA NA NA
Raltegravir Raltegravir 400mg filmcoated tablet Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Wenning 2009 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=10) NA NA NA
Raltegravir Raltegravir 50 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 50mg - Raltegravir - PO - 50 mg - Plasma - agg. (n=24) NA NA NA
Raltegravir Raltegravir 800 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) Iwamoto 2008 - 800mg - Raltegravir - PO - 800 mg - Plasma - agg. (n=24) NA NA NA
Title Section.Ref PK-Parameter Plot.Type Subunits Artifacts Group.Caption Group.Color Group.Symbol ChartWidth ChartHeight AxisSize LegendSize OriginSize FontFamilyName WatermarkSize X_Dimension X_GridLines X_Scaling Y_Dimension Y_GridLines Y_Scaling
UGT1A1 and UGT1A9 Inhibition DDI qualification-of-ugt-mediated-ddi AUC predictedVsObserved NA Plot Atazanavir + Raltegravir #b2182b Circle NA NA NA NA NA NA NA NA NA NA NA NA NA
NA NA CMAX residualsVsObserved NA GMFE Mefenamic acid + Dapagliflozin #2166ac Square NA NA NA NA NA NA NA NA NA NA NA NA NA
NA NA NA NA NA Measure NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
NA NA NA NA NA Table NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Project Simulation_Control Control.StartTime Control.EndTime Control.TimeUnit Simulation_Treatment Treatment.StartTime Treatment.EndTime Treatment.TimeUnit Output Plot.Title Group.Title Observed.data ObsDataRecordID
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir 0 9999 h Iwamoto2008_Raltegravir+Atazanavir 144 9999 h Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) UGT1A1 and UGT1A9 Inhibition DDI Atazanavir + Raltegravir DDI Ratios 571
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir 0 9999 h Krishna2016_Raltegravir+Atazanavir 144 9999 h Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) UGT1A1 and UGT1A9 Inhibition DDI Atazanavir + Raltegravir DDI Ratios 575
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir 168 180 h Neely2010_Raltegravir+Atazanavir 168 192 h Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) UGT1A1 and UGT1A9 Inhibition DDI Atazanavir + Raltegravir DDI Ratios 573
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir 96 108 h Zhu2010_Raltegravir+Atazanavir 600 612 h Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) UGT1A1 and UGT1A9 Inhibition DDI Atazanavir + Raltegravir DDI Ratios 579
Mefenamic_acid-Dapagliflozin-DDI DDI Control - Dapagliflozin - Kasichayanula 2013a 0 9999 h DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a 24 9999 h Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) UGT1A1 and UGT1A9 Inhibition DDI Mefenamic acid + Dapagliflozin DDI Ratios 642
Title Section.Reference PK-Parameter Artifacts Group.Caption Group.Color Group.Symbol ChartWidth ChartHeight AxisSize LegendSize OriginSize FontFamilyName WatermarkSize X_Dimension X_GridLines X_Scaling Y_Dimension Y_GridLines Y_Scaling
Project Simulation Output Plot.Title Group.Title Observed.data ObservedDataRecordId
Atazanavir Acosta2007_300mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir Agarwala2003_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir Agarwala2005a_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir Agarwala2005b_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-004_400mg_TreatmentA Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungFemales Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-014_400mg_YoungMales Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-028_200mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-028_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-040_200mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-040_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-040_800mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-056_300mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-076_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir FDA-ClinPharmReview_AI424-076_800mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir Martin2008_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir Zhu2010_300mg_Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir Zhu2011_400mg Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Iwamoto2008_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Krishna2016_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Neely2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) NA NA NA NA
Atazanavir-Raltegravir-DDI Zhu2010_Raltegravir+Atazanavir Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin IV 0.08 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO MD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO MD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO MD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO MD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO MD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO MD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO MD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO MD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO MD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO MD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO SD 10 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO SD 10 mg IC tablet (Chang 2015) (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO SD 100 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO SD 2.5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO SD 20 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO SD 250 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO SD 250 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO SD 250 mg fed (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO SD 250 mg fed (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO SD 5 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO SD 5 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO SD 5 mg IC tablet (Chang 2015) (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces NA NA NA NA
Dapagliflozin PO SD 50 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Dapagliflozin PO SD 500 mg (perm) Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine NA NA NA NA
Dapagliflozin PO SD 500 mg (perm) Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Mefenamic_acid PO MD 500 mg loading / 250 mg every 6 h Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) NA NA NA NA
Mefenamic_acid PO SD 250 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) NA NA NA NA
Mefenamic_acid PO SD 500 mg Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) NA NA NA NA
Mefenamic_acid-Dapagliflozin-DDI DDI Control - Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Mefenamic_acid-Dapagliflozin-DDI DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) NA NA NA NA
Mefenamic_acid-Dapagliflozin-DDI DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 10 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 100 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 100 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 1200 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 1600 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 200 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 200 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 25 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 400 mg filmcoated tablet md Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 400mg (granules in suspension) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 400mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 400mg chewable fasted Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 400mg chewable fed Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 400mg filmcoated tablet Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 50 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Raltegravir Raltegravir 800 mg (lactose formulation) Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) NA NA NA NA
Section.Reference Title Content Parent.Section
introduction Introduction NA NA
objective Objective Content/Qualification_DDI_UGT_objective.md introduction
ugt-ddi-network UGT DDI Network Content/Qualification_DDI_UGT_network_description.md introduction
network-atazanavir-raltegravir-ddi Atazanavir - Raltegravir DDI Content/ATV-RAL-DDI.md ugt-ddi-network
network-mefenamic-acid-dapagliflozin-ddi Mefenamic acid - Dapagliflozin DDI Content/MEFA-Dapa-DDI.md ugt-ddi-network
qualification-of-ugt-mediated-ddi Qualification of Use Case UGT-mediated DDI Content/Intro_evaluation_DDI_network.md NA
ct-profiles Concentration-Time Profiles Content/Intro_evaluation_CTprofiles.md NA
atazanavir-raltegravir-ddi Atazanavir - Raltegravir DDI NA ct-profiles
mefenamic-acid-dapagliflozin-ddi Mefenamic acid - Dapagliflozin DDI NA ct-profiles
main-references References Content/References.md NA
appendix Appendix NA NA
osp-introduction Open Systems Pharmacology Suite (OSPS) Introduction https://raw.githubusercontent.com/Open-Systems-Pharmacology/Qualification-text-modules/v1.3/OSPS_Introduction.md appendix
mathematical-implementation-of-ddi Mathematical Implementation of Drug-Drug Interactions https://raw.githubusercontent.com/Open-Systems-Pharmacology/Qualification-text-modules/v1.3/Mathematical_Implementation_of_DDI.md appendix
automatic-requalification-workflow Automatic (re)-qualification workflow https://raw.githubusercontent.com/Open-Systems-Pharmacology/Qualification-text-modules/v1.3/Qualification_Workflow.md appendix
Path
Content/titlepage.md
Project BB-Type BB-Name Section.Reference
Mefenamic_acid-Dapagliflozin-DDI Individual Standard_Adult_UGT NA
Mefenamic_acid-Dapagliflozin-DDI Compound Mefenamic acid NA
Mefenamic_acid-Dapagliflozin-DDI Compound Dapagliflozin NA
Mefenamic_acid-Dapagliflozin-DDI Formulation Ponstan capsule NA
Atazanavir-Raltegravir-DDI Compound Raltegravir NA
Atazanavir-Raltegravir-DDI Compound Atazanavir NA
Atazanavir-Raltegravir-DDI Formulation Reyataz capsule NA
Atazanavir-Raltegravir-DDI Formulation filmcoated tablet (original Merck formulation) NA
Mefenamic_acid Individual Standard_Adult NA
Mefenamic_acid Compound Mefenamic acid NA
Mefenamic_acid Protocol PO MD 500 mg loading / 250 mg every 6 h NA
Mefenamic_acid Protocol 250 mg SD NA
Mefenamic_acid Protocol 500 mg SD NA
Mefenamic_acid Event breakfast NA
Mefenamic_acid Event snack (MEFA) NA
Mefenamic_acid Formulation Ponstan capsule NA
Dapagliflozin Individual Standard_Adult_UGT NA
Dapagliflozin Compound Dapagliflozin NA
Dapagliflozin Protocol IV 0.08 mg NA
Dapagliflozin Protocol PO SD 50 mg NA
Dapagliflozin Protocol PO SD 2.5 mg NA
Dapagliflozin Protocol PO SD 5 mg NA
Dapagliflozin Protocol PO SD 10 mg NA
Dapagliflozin Protocol PO SD 20 mg NA
Dapagliflozin Protocol PO SD 100 mg NA
Dapagliflozin Protocol PO SD 250 mg NA
Dapagliflozin Protocol PO SD 500 mg NA
Dapagliflozin Protocol PO MD 2.5 mg NA
Dapagliflozin Protocol PO MD 10 mg NA
Dapagliflozin Protocol PO MD 20 mg NA
Dapagliflozin Protocol PO MD 50 mg NA
Dapagliflozin Protocol PO MD 100 mg NA
Dapagliflozin Event breakfast NA
Dapagliflozin Formulation Dissolved NA
Dapagliflozin Formulation IC tablet (Chang 2015) NA
Raltegravir Individual Standard European Male for PEQ NA
Raltegravir Compound Raltegravir NA
Raltegravir Protocol Iwamoto 2008 400mg PO (Figure 1) omeprazole study NA
Raltegravir Protocol Iwamoto 2008 10mg PO (Figure 2) Safety-Tolerability-PK study NA
Raltegravir Protocol Iwamoto 2008 25mg PO (Figure 2) Safety-Tolerability-PK study NA
Raltegravir Protocol Iwamoto 2008 50mg PO (Figure 2) Safety-Tolerability-PK study NA
Raltegravir Protocol Iwamoto 2008 100mg PO (Figure 2) Safety-Tolerability-PK study NA
Raltegravir Protocol Iwamoto 2008 200mg PO (Figure 2) Safety-Tolerability-PK study NA
Raltegravir Protocol Iwamoto 2008 800mg PO (Figure 2) Safety-Tolerability-PK study NA
Raltegravir Protocol Iwamoto 2008 1200mg PO (Figure 2) Safety-Tolerability-PK study NA
Raltegravir Protocol Iwamoto 2008 1600mg PO (Figure 2) Safety-Tolerability-PK study NA
Raltegravir Protocol Markowitz 2006 100mg bid 10d NA
Raltegravir Protocol Markowitz 2006 200mg bid 10d NA
Raltegravir Protocol Markowitz 2006 400mg bid 10d NA
Raltegravir Event Food NA
Raltegravir Formulation Weibull (lactose formulation) NA
Raltegravir Formulation chewable tablet NA
Raltegravir Formulation filmcoated tablet (original Merck formulation) NA
Raltegravir Formulation Weibull (granules) NA
Atazanavir Individual Agarwala2003 NA
Atazanavir Individual Agarwala2005a NA
Atazanavir Individual Agarwala2005b NA
Atazanavir Individual Martin2008 NA
Atazanavir Individual Zhu2011 NA
Atazanavir Individual WhiteAmericanMale NA
Atazanavir Individual WhiteAmericanFemale NA
Atazanavir Individual Zhu2010 NA
Atazanavir Individual Acosta2007 NA
Atazanavir Compound Atazanavir NA
Atazanavir Protocol 400mg_QD_7days NA
Atazanavir Protocol 400mg_QD_6days NA
Atazanavir Protocol 400mg_QD_5days NA
Atazanavir Protocol 200mg_QD_5days NA
Atazanavir Protocol 800mg_QD_5days NA
Atazanavir Protocol 400mg_SD NA
Atazanavir Protocol 300mg_BID_7days_at120h NA
Atazanavir Protocol 300mg_BID NA
Atazanavir Protocol 200mg_QD_6days NA
Atazanavir Protocol 300mg_QD_10days NA
Atazanavir Protocol 800mg_QD_6days NA
Atazanavir Event High-fat breakfast NA
Atazanavir Event Light meal NA
Atazanavir Formulation Reyataz capsule NA
Mefenamic_acid-Dapagliflozin-DDI Protocol Dapagliflozin - PO SD 10 mg NA
Mefenamic_acid-Dapagliflozin-DDI Protocol Mefenamic acid - PO MD 500 mg loading / 250 mg every 6 h NA
Mefenamic_acid-Dapagliflozin-DDI Protocol Dapagliflozin - PO SD 10 mg (with MEFA) NA
Mefenamic_acid-Dapagliflozin-DDI Event snack (MEFA) NA
Mefenamic_acid-Dapagliflozin-DDI Formulation Solution NA
Atazanavir-Raltegravir-DDI Individual Neely2010 NA
Atazanavir-Raltegravir-DDI Individual HispanicMale NA
Atazanavir-Raltegravir-DDI Individual Krishna2016 NA
Atazanavir-Raltegravir-DDI Individual Zhu2010 NA
Atazanavir-Raltegravir-DDI Protocol 400mg_BID_8days NA
Atazanavir-Raltegravir-DDI Protocol Raltegravir_400mg_QD_8days NA
Atazanavir-Raltegravir-DDI Protocol Raltegravir_100mg_at144h NA
Atazanavir-Raltegravir-DDI Protocol Raltegravir_100mg NA
Atazanavir-Raltegravir-DDI Protocol Raltegravir_1200mg NA
Atazanavir-Raltegravir-DDI Protocol Raltegravir_1200mg_at144h NA
Atazanavir-Raltegravir-DDI Protocol Raltegravir_400mg_BID_5days NA
Atazanavir-Raltegravir-DDI Protocol Raltegravir_400mg_BID_14days_at288h NA
Atazanavir-Raltegravir-DDI Protocol 300mg_BID_14days_at288h NA
Atazanavir-Raltegravir-DDI Protocol 400mg_QD_9days NA
Atazanavir-Raltegravir-DDI Protocol 400mg_QD_8days NA
Atazanavir-Raltegravir-DDI Event High-fat breakfast NA
Atazanavir-Raltegravir-DDI Event Light meal NA
ChartWidth ChartHeight AxisSize LegendSize OriginSize FontFamilyName WatermarkSize
500 400 11 9 9 Arial 40
Plot Type Dimension Unit GridLines Scaling
GOFMergedPlotsPredictedVsObserved X Concentration (mass) µg/l FALSE Log
GOFMergedPlotsPredictedVsObserved Y Concentration (mass) µg/l FALSE Log
GOFMergedPlotsResidualsOverTime X Time h FALSE Linear
GOFMergedPlotsResidualsOverTime Y Dimensionless FALSE Linear
DDIRatioPlotsPredictedVsObserved X Dimensionless FALSE Log
DDIRatioPlotsPredictedVsObserved Y Dimensionless FALSE Log
DDIRatioPlotsResidualsVsObserved X Dimensionless FALSE Log
DDIRatioPlotsResidualsVsObserved Y Dimensionless FALSE Log
ComparisonTimeProfile X Time h FALSE Linear
ComparisonTimeProfile Y Concentration (mass) ng/ml FALSE Log
PKRatioPlots X Age year(s) FALSE Linear
PKRatioPlots Y Dimensionless FALSE Log
BuildingBlock BuildingBlockOrSimulation TimeUnit Symbol Color Dimension Scaling FontFamilyName ArtifactsRatioPlots ArtifactsGOFPlots subunitsDDIRatioPlots PK.Parameter ObservedDataType GOFMergedPlotType DDIRatioPlotType Treatment Boolean AxesSettingsPlots
Individual Individual s Circle #CC6677 Age Linear Arial Table GMFE Mechanism AUC DDIRatio predictedVsObserved predictedVsObserved X FALSE GOFMergedPlotsPredictedVsObserved
Population Population min Square #332288 Amount Log Tahoma GMFE Plot Perpetrator CMAX PKRatio residualsOverTime residualsVsObserved NA TRUE GOFMergedPlotsResidualsOverTime
Compound Compound h Diamond #DDCC77 Concentration (mass) NA TimesNewRoman Plot Measure Victim C_max TimeProfile NA NA NA NA DDIRatioPlotsPredictedVsObserved
Protocol Protocol day(s) Asterisk #117733 Concentration (molar) NA MicrosoftSansSerif Measure NA NA C_max_norm NA NA NA NA NA DDIRatioPlotsResidualsVsObserved
Event Event week(s) Cross #88CCEE Fraction NA NA NA NA NA C_max_tD1_tD2 NA NA NA NA NA ComparisonTimeProfile
Formulation Formulation month(s) Triangle #882255 Mass NA NA NA NA NA C_max_tD1_tD2_norm NA NA NA NA NA PKRatioPlots
ObserverSet ObserverSet year(s) InvertedTriangle #44AA99 Time NA NA NA NA NA C_max_tDLast_tEnd NA NA NA NA NA NA
ExpressionProfile ExpressionProfile NA Plus #999933 Dimensionless NA NA NA NA NA C_max_tDLast_tEnd_norm NA NA NA NA NA NA
NA Simulation NA Star #AA4499 NA NA NA NA NA NA t_max NA NA NA NA NA NA
NA NA NA Pentagon #DDDDDD NA NA NA NA NA NA t_max_tD1_tD2 NA NA NA NA NA NA
NA NA NA Hexagon NA NA NA NA NA NA NA t_max_tDLast_tEnd NA NA NA NA NA NA
NA NA NA ThinCross NA NA NA NA NA NA NA C_trough_tD2 NA NA NA NA NA NA
NA NA NA ThinPlus NA NA NA NA NA NA NA C_trough_tDLast NA NA NA NA NA NA
NA NA NA CircleOpen NA NA NA NA NA NA NA C_tEnd NA NA NA NA NA NA
NA NA NA DiamondOpen NA NA NA NA NA NA NA AUC_tEnd NA NA NA NA NA NA
NA NA NA HexagonOpen NA NA NA NA NA NA NA AUC_tEnd_norm NA NA NA NA NA NA
NA NA NA InvertedTriangleOpen NA NA NA NA NA NA NA AUC_inf NA NA NA NA NA NA
NA NA NA PentagonOpen NA NA NA NA NA NA NA AUC_inf_norm NA NA NA NA NA NA
NA NA NA SquareOpen NA NA NA NA NA NA NA AUC_tD1_tD2 NA NA NA NA NA NA
NA NA NA StarOpen NA NA NA NA NA NA NA AUC_tD1_tD2_norm NA NA NA NA NA NA
NA NA NA TriangleOpen NA NA NA NA NA NA NA AUC_tDLast_minus_1_tDLast NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA AUC_tDLast_minus_1_tDLast_norm NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA AUC_inf_tD1 NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA AUC_inf_tD1_norm NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA AUC_inf_tDLast NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA AUC_inf_tDLast_norm NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA MRT NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA Thalf NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA Thalf_tDLast_tEnd NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA FractionAucLastToInf NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA CL NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA Vss NA NA NA NA NA NA
NA NA NA NA NA NA NA NA NA NA NA Vd NA NA NA NA NA NA
  • Use data validation dropdowns: Don’t type free text where dropdowns exist (section references, projects, simulations)
  • Check dependencies: If you rename or delete sections, update references to them in plot sheets
  • Test incrementally: After major changes, convert to JSON and test before making more edits
  • Keep backups: Save a copy before making extensive changes
  • Document rationale: Use Excel comments to note why changes were made
  • Validate section references: Ensure all section references in evaluation sheets match defined sections

For detailed worksheet descriptions, see the Excel Template Documentation.

Step 4: Convert Back to JSON

After editing, convert the Excel file back to a JSON qualification plan:

excelToQualificationPlan(
  excelFile = excelFile,
  qualificationPlan = paste0("updated-", qualificationPlan)
)

Note: Using paste0("updated-", qualificationPlan) creates a new file with an “updated-” prefix, preserving your original. This is recommended for safety.

Validation Process

The function validates your edits:

  • Section references: All references must match sections in the Sections sheet
  • Project/simulation names: Must match definitions in the Projects, Simulations_Outputs, and Simulations_ObsData sheets
  • Building block references: Parent projects must exist
  • Required columns: All mandatory columns must be present
  • Lookup values: Values must match allowed options in Lookup sheet

Handling Validation Errors

If validation fails, you’ll see error messages like:

Error: Invalid section reference 'old-section' in All_Plots sheet
Error: Project 'NonExistent' not found in Projects sheet
Error: Missing required column 'Section Reference' in CT_Plots sheet

To fix: 1. Open the Excel file 2. Navigate to the problematic sheet 3. Correct the error (use data validation dropdowns when available) 4. Save and convert again

Successful Conversion

Upon success, you’ll see a confirmation message. The updated qualification plan JSON is ready for use with the OSP Suite Qualification Runner.

Next Steps

After updating your qualification plan:

  1. Run the qualification: Execute with the OSP Suite Qualification Runner
  2. Review the generated report: Verify changes appear as expected
  3. Check plots and sections: Ensure evaluations are in the right sections with correct configurations
  4. Iterate if needed: If further adjustments are required, convert back to Excel and edit again

Common Update Scenarios

Scenario 1: Reorganizing Report Structure

Goal: Move validation results from “Methods” to a new “Validation” section

Steps: 1. In Sections sheet, create new “Validation” section 2. In All_Plots, CT_Plots, GOF_Plots, update Section Reference for validation plots 3. Convert and verify

Scenario 2: Excluding Certain Plots

Goal: Remove specific simulation outputs from the report

Steps: 1. In All_Plots sheet, find the outputs to exclude 2. Clear the Section Reference column for those rows 3. Convert - plots without section references are excluded

Scenario 3: Adding New Comparison Plots

Goal: Create a new CT plot comparing multiple simulations

Steps: 1. In CT_Plots, add a row with unique PlotId and configuration 2. In CT_Mapping, add rows mapping simulations and observed data to this PlotId 3. Assign the plot to a section using Section Reference 4. Convert and test

Scenario 4: Updating Building Block Inheritance

Goal: Change a project to inherit a compound from a different parent

Steps: 1. In BB sheet, find the building block row 2. Change the Parent-Project column value 3. Verify the parent project exists and has the building block 4. Convert and test

Scenario 5: Changing Plot Appearance

Goal: Make all plots larger and higher resolution

Steps: 1. In GlobalPlotSettings, update Width, Height, and Resolution 2. Optionally update font sizes 3. Convert - all plots will use new settings

Troubleshooting

Issue: “Section reference not found”

Cause: You referenced a section that doesn’t exist

Fix: Check the Sections sheet for valid section references and update your references

Issue: “Invalid project name in mapping”

Cause: You typed a project name that doesn’t match the Projects sheet

Fix: Use the data validation dropdown to select from valid projects

Issue: “Building block inheritance creates circular dependency”

Cause: Project A inherits from Project B, which inherits from Project A

Fix: Review the BB sheet and remove circular inheritance

Issue: “Plot appears in wrong section in report”

Cause: Section reference is incorrect or section hierarchy is wrong

Fix: Verify section references and parent-child relationships in Sections sheet

Advanced Tips

  • Bulk updates: Use Excel’s find-and-replace to update multiple section references at once
  • Copy plot configurations: Duplicate rows in plot sheets to create similar plots quickly
  • Filter and sort: Use Excel’s filter feature to focus on specific projects or sections
  • Conditional formatting: Add your own conditional formatting to highlight specific items
  • Freeze panes: Freeze header rows to keep column names visible while scrolling